Medical Device Manufacturer · US , Raynham , MA

Omnlife Science - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2008

Recent clearances: OMNI Interface Acetabular System, APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM), APEX KNEE MODULAR TIBIA SYSTEM

View 6 510(k) Devices ↓
6
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Omnlife Science Orthopedic ✕

6 devices
1-6 of 6
Cleared Jan 26, 2015
OMNI Interface Acetabular System
K142201 · LPH
Orthopedic · 168d
Cleared Dec 02, 2011
APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
K112779 · LPH
Orthopedic · 67d
Cleared Sep 28, 2010
APEX KNEE MODULAR TIBIA SYSTEM
K101994 · JWH
Orthopedic · 75d
Cleared Jun 30, 2010
APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810,...
K101575 · LPH
Orthopedic · 23d
Cleared May 28, 2010
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44...
K100151 · KWY
Orthopedic · 129d
Cleared Feb 14, 2008
MODIFICATION TO: APEX KNEE SYSTEM
K073602 · JWH
Orthopedic · 55d
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